Since 2012, MHLW health science grant study on "Pharmaceutical quality control system by QbD and control strategy through life cycle of drug products" has been conducted with a number of professionals from various fields. This mock intends to illustrate the contents to be included in CTD 2.3.P.2 “Pharmaceutical Development” regarding drug product developed using the Quality by Design (QbD) methodology presented in ICH Q8, Q9 and Q10. It takes into CTD Module 2 (Quality Overall Summary). In addition, in order to help the users’ better understanding, some parts of the contents corresponding to 2.3.P.3 and 2.3.P.5 are also included in this mock.
The study group accepts comments on three draft guidance documents to finalize the documents. They are posted at a home page of the National Institute of Health Sciences

Sakura Bloom Tablets P2 Mock (draft) 　NEW!

Constructive comments may be sent to comment2013(AT)nihs.go.jp* by December 14, 2014.
* Replace (AT) by @ .

Comments should be written in Japanese or in English. At the beginning of comments, name of guidance, name of organization, organization function should be written. Reasons for comments are highly appreciated.

Principal Scientist of the Grant Study

Noriko Katori, Ph.D.
Chief, Third Section，Division of Drugs
National Institute of Health Sciences
1-18-1 Kamiyohga, Setagayaku, Tokyo 158-8501

To Drugs Division Home Page

Last edition:Nov.. 17, 2014